Head of QA Injectables Manufacturing
il y a 3 semaines
**Make your mark for patients**
We're on the lookout for a Head of QA Injectables Manufacturing to join our team in the Internal Manufacturing department, based in our office in Braine, Belgium.
About the Role
Together with appropriate management, responsible for the implementation and maintenance of an effective Quality Management System to assure that:
- Local technical operations related to the manufacturing of injectable pharmaceutical products (DP) complies with applicable national and/or international regulations and guidelines (GMP) & relevant company Quality Policies.
- Injectable pharmaceutical Products are manufactured and supplied in accordance with the company Quality Standards.
- To pro-actively help operations identify, develop, and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirement.
Who You'll Work With
You will report directly to the Head of Site QA Operations & Site QP, and you will collaborate closely with various stakeholders including Site QA staff, Braine Site Staff, the UCB injectables community, and Regulatory Affairs.
What You'll Do
Compliance and Quality Systems:
- Ensure that all Quality Assurance (QA) team operations align with relevant company quality systems and cGMP (current Good Manufacturing Practices).
- Ensure QA oversight of shop floor operations with company procedures and regulatory requirements.
- Facilitate timely and accurate batch approval or rejection according to regulations and established procedures.
- Provide necessary QA support to the Qualified Person (QP) for informed decisions.
- Internal Customer Relationships:
- Manage relationships with internal stakeholders, including the Head of Injectable Manufacturing.
- Ensure timely follow-up on product-related deviations, change controls, investigations, complaints, and release processes.
Team Leadership and Talent Development:
- Lead and develop the QA team, fostering talent recognition and growth.
- Be prepared to provide backup support to the team as needed.
- Actively contribute to simplifying and streamlining processes.
- Identify and remove roadblocks hindering quality improvement.
- Review and optimize procedures where necessary.
Inspections and Technical Expertise:
- Act as fronter during inspections by relevant health authorities.
- Provide answers to audit/inspection reports and develop relevant action plans.
- Offer technical expertise based on experience and share with injectable community.
- Interpret and provide direction to company management regarding Quality Assurance matters, regulatory CMC (Chemistry, Manufacturing, and Controls) files, and company policies.
Critical Issue Escalation and Solutions:
- Escalate critical quality issues to senior management promptly.
- Propose effective solutions to address challenges.
Interested? For this role, we're seeking the following qualifications, experience, and skills:
- Master's Degree
- Knowledge of worldwide regulations and best practice pertaining to GMP with special emphasis on injectable.
- Ability to plan and direct the actions of a group of professional Quality Assurance personnel.
- Demonstrate a fact-based decision-making process, accountability and delivering attitude.
- Ability to manage effectively and strategically plan to meet company objectives both short and long term.
- Excellent team player attitude and customer oriented.
- Fluent in English
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
-
Head of QA Injectables Manufacturing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsWe're on the lookout for a Head of QA Injectables Manufacturing to join our team in the Internal Manufacturing department, based in our office in Braine, Belgium.About the RoleTogether with appropriate management, responsible for the implementation and maintenance of an effective Quality Management System to assure that:Local...
-
Quality Assurance Officer Injectable Manufacturing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB S.A. Temps pleinMake your mark for patientsWe are looking for a Quality Assurance Officer Injectable Manufacturing who is a teamplayer, stress resistant with a strong sense of ethics to join us in our Braine Site QA Operations team, based in our UCB Braine-l'Alleud Campus office in Walloon Brabant, Belgium.About the roleTogether with appropriate management, you are...
-
QA Manufacturing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Hobson Prior Temps pleinHobson Prior are seeking for a QA Manufacturing (Project) for a pharmaceutical establishment on a permanent basis located in Braine-l'Alleud & Paris. Our client is focused on improving the lives of many.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities: For this position, you will uphold the...
-
Head of Compliance
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB S.A. Temps pleinMake your mark for patientsWe are looking for a Head of Compliance who is rigorous, field oriented and able to lead a team to join us in our Sterile manufacturing department, based in our UCB Campus office in Braine-l'Alleud, Walloon Brabant, Belgium.About the roleAs part of the support to production and project activities in the Sterile Manufacturing...
-
External Manufacturing Operations Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patients External Manufacturing Operations Lead Pharma DP As a UCB External Manufacturing Operations Lead, you like to work in an environment where you can: Be accountable for leading the operational management of UCB's global Contract Manufacturers / strategic vendors. Lead the UCB Vendor Teams (with members of Supply Chain,...
-
Head of Manufacturing Finance Business Partners
il y a 2 semaines
Braine-l'Alleud, Belgique UCB Temps plein**Make your mark for patients** To strengthen **our I2I Supply & Technology & Functions **team, based in Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of **Head of Manufacturing Finance Business Partners**. **About the role** As the Head of Manufacturing Finance Business Partners, you'll lead a global team...
-
Head of Manufacturing
il y a 4 jours
Braine-l'Alleud, Belgique PolyPeptide Belgium Temps pleinPolyPeptide Group AG et ses filiales ("PolyPeptide") est une entreprise de **production de principes actifs pharmaceutiques à base de peptides et d'oligonucléotides (CDMO)**. En soutenant ses clients, principalement issus des secteurs pharmaceutique et biotechnologique, l’entreprise contribue à la santé de millions de patients à travers le monde....
-
Head of Manufacturing
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique PolyPeptide Belgium Temps pleinPolyPeptide Group AG et ses filiales ("PolyPeptide") est une entreprise de **production de principes actifs pharmaceutiques à base de peptides et d'oligonucléotides (CDMO)**.En soutenant ses clients, principalement issus des secteurs pharmaceutique et biotechnologique, l'entreprise contribue à la santé de millions de patients à travers le monde....
-
External Manufacturing Operations Lead
il y a 2 semaines
Braine-l'Alleud, Belgique UCB Temps plein**Make your mark for patients** External Manufacturing Operations Lead Pharma DP As a UCB External Manufacturing Operations Lead, you like to work in an environment where you can: - Be accountable for leading the operational management of UCB's global Contract Manufacturers / strategic vendors. - Lead the UCB Vendor Teams (with members of Supply Chain,...
-
External Manufacturing Operations Lead
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsExternal Manufacturing Operations Lead Pharma DPAs a UCB External Manufacturing Operations Lead, you like to work in an environment where you can:Be accountable for leading the operational management of UCB's global Contract Manufacturers / strategic vendors. Lead the UCB Vendor Teams (with members of Supply Chain, Quality...
-
External Manufacturing Operations Lead
il y a 17 heures
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsExternal Manufacturing Operations Lead Pharma DP As a UCB External Manufacturing Operations Lead, you like to work in an environment where you can: Be accountable for leading the operational management of UCB's global Contract Manufacturers / strategic vendors. Lead the UCB Vendor Teams (with members of Supply Chain, Quality...
-
External Manufacturing Operations Lead
il y a 24 heures
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsExternal Manufacturing Operations Lead Pharma DP As a UCB External Manufacturing Operations Lead, you like to work in an environment where you can: Be accountable for leading the operational management of UCB's global Contract Manufacturers / strategic vendors. Lead the UCB Vendor Teams (with members of Supply...
-
Technicien QA
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique PolyPeptide Belgium Temps pleinPrêt pour votre prochain challenge?PolyPeptide recrute un "**Quality Operations technician**" pour son département QA.L'objectif de la fonction est d'être l'interface entre les départements opérationnels et QA, que ce soit en termes de revue documentaire, de coaching de l'esprit qualité, ou de la gestion des situations imprévues.L'atout majeur de la...
-
QA Technician
Il y a 2 mois
Braine-l'Alleud, Belgique Start People Temps pleinStart People recherche pour l'un de ses Partenaires un **QA Technician (h/f/x**). En tant que **QA Technician (h/f/x)**, vos tâches seront de: - Participer à la revue de la documentation de production et analytique avant le release de l’API - Participer à la préparation des dossiers de release de l’API - Etre le premier contact de la production...
-
Technicien QA
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique PolyPeptide Belgium Temps pleinPrêt pour votre prochain challenge?PolyPeptide recrute un "**Quality Operations technician**" pour son département QA.L'objectif de la fonction est d'être l'interface entre les départements opérationnels et QA, que ce soit en termes de revue documentaire, de coaching de l'esprit qualité, ou de la gestion des situations imprévues.L'atout majeur de la...
-
Technicien.ne QA
il y a 2 semaines
Braine-l'Alleud, Belgique Actief Interim Temps pleinPrêt à relever un nouveau défi dans une société en plein développement?Travailler sur le terrain comme technicien QA en production vous motive particulièrement?Pour une société renommée active dans la production pharmaceutique et biotechnologique nous recherchons un.e Technicien.ne QA.Quelles seront vos tâches en tant que Quality Operations...
-
QA Technician
il y a 3 semaines
Braine-l'Alleud, Belgique Start People Temps pleinNotre Partenaire est actif dans le secteur Pharmaceutique Description de la fonction Start People recherche pour l'un de ses Partenaires un QA Technician (h/f/x).En tant que QA Technician (h/f/x), vos tâches seront de:Participer à la revue de la documentation de production et analytique avant le release de l’APIParticiper à la préparation des...
-
QA Technician
Il y a 2 mois
Braine-l'Alleud, Belgique Start People Temps pleinNotre Partenaire est actif dans le secteur Pharmaceutique Description de la fonction Start People recherche pour l'un de ses Partenaires un QA Technician (h/f/x).En tant que QA Technician (h/f/x), vos tâches seront de:Participer à la revue de la documentation de production et analytique avant le release de l’APIParticiper à la préparation des...
-
QA Technician
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Start People Charleroi Temps pleinDescriptionStart People recherche pour l'un de ses Partenaires un QA Technician (h/f/x).En tant que QA Technician (h/f/x), vos tâches seront de:Participer à la revue de la documentation de production et analytique avant le release de l'APIParticiper à la préparation des dossiers de release de l'APIEtre le premier contact de la production pour les aspects...
-
Technicien QA
il y a 7 jours
Braine-l'Alleud, Belgique PolyPeptide Belgium Temps pleinPrêt pour votre prochain challenge? PolyPeptide recrute un "**Quality Operations technician**" pour son département QA. L'objectif de la fonction est d'être l’interface entre les départements opérationnels et QA, que ce soit en termes de revue documentaire, de coaching de l’esprit qualité, ou de la gestion des situations imprévues. L’atout...
